About this trial
The purpose of this study is to provide an effective repetitive transcranial magnetic stimulation (rTMS) treatment for depressive symptoms in patients with schizophrenia. Schizophrenia patients with depressive symptoms will be exposed to rTMS to improve their symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female ages between ages 18-60 years.
Ability to give written informed consent (age 18 or above).
Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10.
Score of Calgary depression scale for schizophrenia (CDSS) ≥ 3.
Disqualifiers
Inability to sign informed consent.
Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but are not limited to: stroke, repeated seizure, history of significant head trauma with cognitive sequela, CNS infection or tumor, other significant brain neurological conditions.
Significant alcohol or other drug use other than nicotine or marijuana dependence.
Inability to refrain from using alcohol and/or marijuana 24 hours or more prior to experiments.
Trial design
Parallel
Treatments tested in this trial
Active rTMS stimulation
DeviceActive H-coil delivered rTMS sessions will be given three times per treatment visit for up to 20 visits for about 4 weeks. There are about 30 minutes breaks between adjacent TMS sessions. Each TMS session takes about 3 to 4 minutes to complete.
Sham rTMS stimulation
DeviceSham H-coil delivered rTMS sessions will be given three times per treatment visit for up to 20 visits for about 4 weeks. There are about 30 minutes breaks between adjacent TMS sessions. Each TMS session takes about 3 to 4 minutes to complete.
Treatment groups
Trial outcomes
Primary outcomes
Brain connectivity as indicated by resting-state functional connectivity (rsFC) values as assessed by functional MRI (fMRI)
rsFC values will be reported as a Z-score with a range of -1 to 1, with greater absolute values indicating stronger brain connectivity.
Secondary outcomes
Electrophysiological response as indicated by mismatch negativity as assessed by electroencephalography (EEG)
Mismatch negativity values will be reported in microvolts (uV). Mismatch negativity is measured by subtracting the averaged response to a set of standard stimuli from the average response to deviant stimuli, and taking the amplitude of this difference in a given timepoint.
Electrophysiological response as indicated by steady-state auditory evoked responses from electroencephalography recording (EEG)
Steady-state auditory evoked responses will be reported. The responses are measured by calculating the ratio of the power at target frequency over power at the surrounding background frequencies. The ration will be obtained in a given timepoint.
Depression as assessed by the Calgary Depression Scale
Total score of the Calgary Depression Scale will be reported and ranges from 0 to 27, with a higher score indicating greater depression.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center, Houston
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator